Home NDC 84803-100 Ultra Violette Supreme Screen Broad Spectrum SPF 50
Product NDC 84803-100
11-digit product format 848030100
Labeler code 84803
Product ID 84803-100_561cbb3d-11b5-8bce-e063-6294a90a871d
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Dosage form CREAM
Route TOPICAL
Labeler Grace and Fire USA Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-01
Substance HOMOSALATE; AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength 70; 30; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Ultra Violette Supreme Screen Broad Spectrum SPF 50
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 70 mg/mL AVOBENZONE 30 mg/mL OCTISALATE 50 mg/mL OCTOCRYLENE 80 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84803-100-05 Ultra Violette Supreme Screen Broad Spectrum SPF 50 5 mL in 1 TUBE CREAM 5 6 84803-100-15 Ultra Violette Supreme Screen Broad Spectrum SPF 50 15 mL in 1 TUBE CREAM 15 6 84803-100-20 Ultra Violette Supreme Screen Broad Spectrum SPF 50 20 mL in 1 BOTTLE, PLASTIC CREAM 20 6 84803-100-21 Ultra Violette Supreme Screen Broad Spectrum SPF 50 20 mL in 1 BOTTLE, PUMP CREAM 20 6 84803-100-50 Ultra Violette Supreme Screen Broad Spectrum SPF 50 50 mL in 1 TUBE CREAM 50 6 84803-100-15 Ultra Violette Mini MatesDuo Pack 15 mL in 1 TUBE CREAM 1 mL in 15 8 g in 100mL 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84803-100 ULTRA VIOLETTE SUPREME SCREEN BROAD SPECTRUM SPF 50 (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) CREAM [GRACE AND FIRE USA INC.] 3 Current NDC, 5 package rows 20241202_24389324-19db-7eb5-e063-6394a90ad7fb.zip 84803-100 ULTRA VIOLETTE MINI MATES DUO PACK (SPF 50) KIT [GRACE AND FIRE USA INC.] 2 Current NDC 20241231_27e377c2-1e68-d4e2-e063-6394a90a2812.zip 84803-100 ULTRA VIOLETTE MINI MATES DUO PACK (SPF 50) KIT [THERMO-PAK COMPANY, INC.] 1 Current NDC 20241231_2a54ed65-12d5-8a96-e063-6394a90a6e02.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84803-100-05 84803010005 5 mL in 1 TUBE (84803-100-05) 5 ml 2024-12-01 No No Current 84803-100-10 84803010010 100 mL in 1 BOTTLE (84803-100-10) 100 ml 2026-07-08 No No Current 84803-100-15 84803010015 15 mL in 1 TUBE (84803-100-15) 15 ml 2024-12-01 No No Current 84803-100-20 84803010020 20 mL in 1 BOTTLE, PLASTIC (84803-100-20) 20 ml 2024-12-01 No No Current 84803-100-21 84803010021 20 mL in 1 BOTTLE, PUMP 20 ml Historical 84803-100-50 84803010050 50 mL in 1 TUBE (84803-100-50) 50 ml 2024-12-01 No No Current